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LME636 /mL

Phase 2

Acute Anterior Uveitis | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jul 2, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02482129Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior UveitisPHASE2 COMPLETED 45Jul 17, 2015Mar 21, 2016Jul 2, 2018 -
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Study Endpoints
Primary Endpoints
Number of Responders at Day 15
Baseline (Day 1), Day 15

Response was defined as a two-step decrease or more from baseline in Anterior Chamber (AC) Cell Grade as per Standardization of Uveitis Nomenclature (SUN). Baseline was defined as the measurement taken before drug administration on Day 1. Subjects receiving rescue treatment on or before Day 15 were considered non-responders. Only one eye contributed to the analysis.

Mean Best Corrected Visual Acuity (BCVA) at Each Visit
Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or Snellen visual acuity chart and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Only one eye contributed to the analysis.

Mean Intraocular Pressure (IOP) at Each Visit
Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.

Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

Slit-lamp biomicroscopy (examination) was performed to evaluate the anterior segment of the eye, including lids/lashes, conjunctiva, cornea, anterior chamber (cells and flare), iris, and lens. Ocular signs were categorized as Aqueous Flare, Aqueous Inflammatory Cell Grade, Keratic Precipitates, Lens, Limbal Injection, Status of Lens, Peripheral Anterior Synechia, and Posterior Synechia. An increase indicates worsening. Only one eye contributed to the analysis.

Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit
Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

The dilated fundus examination was performed to evaluate the health of the vitreous, optic disc, retinal vessels, macula, and retinal periphery. An increase indicates worsening. Only one eye contributed to the analysis.

Secondary Endpoints
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
Baseline (Day 1), Up to Day 29
Mean Change From Baseline in BCVA at Each Visit
Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Time-to-Response
Baseline (Day 1), Up to Day 15
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LME636EXPERIMENTALLME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
DexamethasoneACTIVE_COMPARATORDexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
Interventions
NameTypeDescription
LME636 60 mg/mL ophthalmic solutionDRUG -
Dexamethasone 0.1% ophthalmic solutionDRUG -
LME636 VehicleDRUGInactive ingredients used for masking purposes
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Provide written informed consent. * Diagnosis of non-infectious AAU in at least 1 eye. * Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature (SUN) in at least one eye. * Able to communicate well with the Investigator, to understand and comply...

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